Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Family Inclusive Early Brain Stimulation (FINEBRAINS)

4 febbraio 2019 aggiornato da: Dr. A.O. Adebiyi, University of Ibadan
Social interaction (in the form of serve and return exchanges) between child and parent are crucial for psychosocial, physical and cognitive development. Parents in sub-Saharan countries are ill-equipped to maximize the benefits from this interaction. The investigators approach builds on the traditional outlook that "it takes a village to raise a child" i.e., not only the parents but other extended family members play a role as caregivers to young children. The investigators intention is to use the existing post-natal/child welfare clinics to deliver an intervention, which uses culturally acceptable videos and active skills building, to deliver health messages and practical skills to women, with the intention that they will subsequently engage and teach their partners and other caregivers about early brain stimulation and child development.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

A two arm cluster randomized control design will be used to select a total of about 400 participants each of the control and intervention groups. The participants will be drawn from primary health care (PHC) centres offering immunization services in Ibadan. In the intervention group, mothers will be trained on early brain stimulation using group video sessions followed by individualised question and answer sessions. These sessions will take place at 6 week and 10 week post natal immunisation visits. The control arm will receive the standard of care - routine immunization care- group health talks.

The child's development will be assessed using the Survey of Wellbeing of Young Children (SWYC) instrument.

Outcome variables will include changes in self-reported early child brain stimulation behaviour and increase in the awareness of parents and significant others on the social and emotional difficulties of children.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

480

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 1 settimana a 1 mese (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • All mothers with live children aged 1-6 weeks

Exclusion Criteria:

  • Mothers of children with moderate to severe birth asphyxia or gross congenital anomalies
  • Mothers who are unable to communicate to provide information

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: A: Edutainment based intervention
This group receives the usual routine immunization at 6, 10, 14 weeks and 9 months and an Edutainment intervention package of limited group (i.e., 3-5 women) drama based video session (Edutainment) followed by a Question and Answer session with mothers on early brain development, parenting skills, communication and negotiating skills at 6 weeks. Mothers will be encouraged to train fathers and other caregivers at home with reinforcement of key messages at subsequent clinic visits. Key messages will be delivered through the use of flip charts at 14 weeks and given to mothers as take home for use in engaging the fathers partners and other caregivers for their child. Reinforcement of key messages at subsequent visits will be through the use of videos and flip chart.
Comportamentale: Edutainment based intervention
Edutainment intervention package
Nessun intervento: B
This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reduction in socio-cognitive deficit as measured by the Survey of Well being of Young Children (SWYC)
Lasso di tempo: 6weeks, 14 weeks, 9months, 12 months and 18 months
Reduced socio-cognitive deficit in the intervention compared to the control group at 18 months of age
6weeks, 14 weeks, 9months, 12 months and 18 months
Improved child stimulation practices as measured by assessment of study constructed self-reported child stimulation practices questionnaire
Lasso di tempo: 18 months
Improved child stimulation practices in the intervention compared to the control group at 18 months of age
18 months
Number of children with developmental delays as measured by The WHO head circumference growth curves and WHO Child Growth Standards
Lasso di tempo: 6weeks to 18 months
Appropriate for Age physical development of children such as Head circumference, Length/height, Weight for Age as measured by The WHO head circumference growth curves and WHO Child Growth Standards
6weeks to 18 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Increased mothers knowledge and competence on child brain stimulation practices as measured by a study constructed domain based questionnaire on knowledge and competence instrument
Lasso di tempo: 9mths -12 months
An increase in mothers knowledge and competence on child brain stimulation practices
9mths -12 months
Mothers engagement of fathers and other caregivers on early brain stimulation as measured by simple questionnaire on mothers self-reported father engagement activity
Lasso di tempo: 6-18months
Mothers are expected to effectively engage their male partners and other caregivers on child development. This will be demonstrated by their success at getting their male partner and other caregivers trained at home.
6-18months
fathers' self- reported engagement and investment in the early childhood development as measured by study derived adaptations of the "Self-Perceptions of the Parental Role scale (SPPR)" and the Early Childhood Study Survey Tool
Lasso di tempo: 18 months
fathers' self- reported engagement and investment in the early childhood development would improve (responsible behaviour, emotional engagement, physical accessibility, material support, involvement in child care, influence in child rearing decisions)
18 months
Increased knowledge and competence of health workers on early brain stimulation as measured by study derived composite questionnaire on knowledge and competence on intervention
Lasso di tempo: 14weeks - 9months
The competence and knowledge of health workers to successfully deliver intervention this intervention after being trained would also be a secondary measure of success.
14weeks - 9months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Ibadan

Collaboratori

Grand Challenges Canada

Investigatori

  • Investigatore principale: Akindele O Adebiyi, MBchB, MPH, College of Medicine, University of Ibadan

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2014

Completamento primario (Effettivo)

1 agosto 2016

Completamento dello studio (Effettivo)

1 agosto 2016

Date di iscrizione allo studio

Primo inviato

22 febbraio 2016

Primo inviato che soddisfa i criteri di controllo qualità

25 febbraio 2016

Primo Inserito (Stima)

3 marzo 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 febbraio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 febbraio 2019

Ultimo verificato

1 febbraio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • AD/13/479/741

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

Decision would be based on research teams final decision after the crucial manuscripts have been published

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Stimolazione cerebrale

Prove cliniche su Edutainment based intervention

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Qatar

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi